Endovenous RFA Versus Ligation and Striping for Varicose Veins

Not Applicable

• Conditions: Varicose Veins of Lower Limb
• Interventions: Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)

• Registration Number: NCT04526626
• Lead Sponsor: The University of Hong Kong-Shenzhen Hospital

Brief Summary

Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-03-25
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-25
• Last Update Submitted: 2020-08-25
• Study First Posted: 2020-08-26
• Last Update Posted: 2020-08-26
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Diagnosis of long saphenous varicose veins

Exclusion Criteria

• Contraindicated to operation due to severe comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High ligation and stripping	Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)	High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins

Primary Outcome Measures

Name	Time	Method
Technical success	up to 24 months	Occlusion of the long saphenous vein
Complications	2 weeks after operation	Deep vein thrombosis, skin burn
Recurrence of varicose vein	up to 24 months	Recurrence of varicose vein

Trial Locations

Locations (1)

University of Hong Kong Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China